Hydroxychloroquine in SARS-CoV-2 (COVID-19) Pneumonia Trial

NCT04382625 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 18244
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Novel coronavirus SARS(Severe Acute Respiratory Syndrome)-CoV-2 was first identified during the outbreak in Wuhan, China in December 2019 with the now resulting pandemic. Aggressive supportive care is the mainstay of treatment currently and rescue with lung protective mechanical ventilation is essential for survival in patients with severe acute respiratory distress syndrome. Despite supportive care, mortality is significant in hospitalized patients in the U.S., especially among patients \> 65 years of age. Pharmacologic treatments to decrease disease severity are urgently needed. Hydroxychloroquine is currently widely used for treatment of autoimmune disease including systemic lupus erythematosus and rheumatoid arthritis, and it has been used to prevent and treat malaria. In vitro and in vivo antiviral activity towards SARS-CoV-2 has been reported. Since hydroxychloroquine has been used for decades its properties as a drug are well known. The investigators propose a pragmatic trial of hydroxychloroquine in moderately ill hospitalized adults with SARS-CoV-2 pneumonia with the hypothesis that hydroxychloroquine reduces severity of acute lung injury caused by SARS-CoV-2 infection.

Conditions

SARS-CoV-2 Pneumonia; COVID-19

Keywords

SARS-CoV-2; Pneumonia; Hydroxychloroquine; COVID-19

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Oxygenation on Day 1 to Day 5

  paO2

  Day 1 of treatment to day 5 of treatment

• Change from Baseline Oxygenation at Day 5

  FIO2

  Day 1 of treatment to day 5 of treatment

Secondary Outcomes (8)

• Intensive Care length of stay

  Day 0 to Day 28

• Required Mechanical Ventilation

  Day 0 to Day 28

• Required Oxygen supplementation

  Day 0 to Day 28

• Hospitalization length of Stay

  Day 0 to Day 28

• Mortality

  Day 0 to Day 28

Study Arms (2)

Hydroxychloroquine (HCQ)

EXPERIMENTAL

Initial dose: HCQ 400mg x 2 (800mg) then 200mg by mouth, three times per day (600mg/24hr period) starting 8 hours after the initial dose for a total of 14 doses over 5 days Plus Usual Care (See below for full description)

Drug: Hydroxychloroquine

Usual Care

NO INTERVENTION

The care of hospitalized patients with covid-19 is evolving with hospital guidelines arising across the U.S. with several commonalities. Patients receive clinical assessment, chest x-ray, covid-19 testing, basic labs (WBC, CMP), and additional labs based on protocol or clinical judgment (ABG, CRP, LDH), antibiotics for possible bacterial pneumonia, acetaminophen for fever, supplemental O2, and consideration for mechanical ventilation. Early intubation over escalating noninvasive support. Low tidal volume ventilation and prone positioning are lung protective strategies used in critically ill covid-19 patients that are based on management of acute respiratory distress syndrome generally. Conservative fluid replacement is used to avoid worsening oxygenation.

Interventions

Hydroxychloroquine DRUG

Hydroxychloroquine is currently widely used for treatment of autoimmune disease including systemic lupus erythematosus and rheumatoid arthritis, and it has been used to prevent and treat malaria.

Also known as: Plaquenil

Hydroxychloroquine (HCQ)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years of age
• SARS-CoV-2 positive per FDA approved RT-PCR (reverse transcription-polymerase chain reaction)
• Acute hypoxia (O2 sat \< 90 % or paO2 \< 60 on room air), or above baseline chronic O2 requirement
• Inpatient admission

You may not qualify if:

• Requires supplemental O2 \>10 litres per minute or mechanical ventilation on admission
• Pregnancy
• AST/ALT \> 5 times the upper limit normal
• Baseline prolonged QT
• Child-Pugh Score B or greater
• ESRD(end-stage renal disease) requiring dialysis
• Known allergy to medication component,
• History of severe G6PD (glucose-6-phosphate dehydrogenase)
• Myasthenia gravis
• Porphyria
• Ongoing treatment for epilepsy
• Life expectancy \< 6 months,
• Patient lacks capacity to provide consent and does not have a surrogate decision maker.
• Retinal Disease

Sponsors & Collaborators

• Kootenai Health: lead
• Washington State University: collaborator

Study Sites (1)

Kootenai Health

Coeur d'Alene, Idaho, 83814, United States

Location

MeSH Terms

Conditions

COVID-19; Pneumonia

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sean Cook, D.O.

  Kootenai Health

  PRINCIPAL INVESTIGATOR

• Jeanette Berg, MD, PhD

  Kootenai Health

  PRINCIPAL INVESTIGATOR

• Sterling McPherson, PhD

  Washington State University

  PRINCIPAL INVESTIGATOR

• John Roll, PhD

  Washington State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center pragmatic randomized open-label trial of hydroxychloroquine + usual care in hospitalized adults with confirmed SARS-CoV-2 infection and acute hypoxia compared to usual care.

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: May 11, 2020
• Study Start: October 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 5, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)